Gastric Acid Secretory DisordersNCT00702533
A New Method for Determining Gastric Acid Output Using a Wireless Capsule
An observational study of Gastric Acid Secretory Disorders, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial summary
Background: Acid-related gastrointestinal disorders are numerous and may require chronic treatment and maintenance, but they are often difficult to diagnose and treat. Gastric analysis is a critical tool for diagnosing and treating acid-related disorders; however, at present it requires a technically difficult… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Acid Secretory Disorders
- What is being tested?
- Pentagastrin Injection BP and Pentagastrin
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jun 2008to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Healthy volunteers and patients with gastric acid secretory disorders
Who may be able to join
- Zollinger-Ellison syndrome (ZES) as diagnosed by one of the following criteria: histologic confirmation of gastrinoma, positive provocative testing with secretin (an increase of >200 pg/mL postinjection), gastric acid hypersecretion (BAO > 15) in the presence of hypergastrinemia (fasting serum gastrin > 99)
- Multiple endocrine neoplasia type-I (MEN1) with suspicion of ZES (hypergastrinemia) undergoing evaluation. MEN-I with ZES
- Hypergastrinemia (serum gastrin > 99)
- Patients must meet at least 1 of the above inclusion criteria and the following:
- Ages equal to or greater than 18 years
- Male, females, all ethnicities
Show all 16Show fewer
- Gastric acid hypersecretion (BAO>15 mEq/hr)
- Conditions with gastric acid hypersecretion including, but not limited to, patients with systemic mastocytosis (SM)
- Refractory GERD (patients with persistant symptoms despite being on standard medical therapy), PUD, and suspected idiopathic gastric hypersecretion
- Patients must meet at least 1 of the above inclusion criteria and the following:
- Ages equal to or greater than 18 years
- Male, females, all ethnicities
- -Medication-controlled (patients whose symptoms resolve with medication):GERD, PUD, and suspected idiopathic gastric hypersecretion
- Patients must meet the above inclusion criteria and the following
- Ages equal to or greater than 18 years
- Male, females, all ethnicities
Who cannot join
- History of gastric surgery (gastrectomy, pyloroplasty)
- Use of bowel motility medications such as, but not limited to, Reglan, Immodium, and Lomotil
- Contraindication to SmartPill: history of gastric bezoar, disorders of swallowing, suspected strictures, fistulas, or physiological GI obstruction, GI surgery within the past three months, severe dysphagia to food or pills, Crohn s Disease or diverticulitis, a subject who uses an implanted or portable electro-mechanical medical device such as a cardiac pacemaker or infusion pump
- Pregnancy and breastfeeding. Females of childbearing potential must be on an acceptable means of birth control and no intercourse in 2 weeks prior to study enrollment.
- Lactose intolerance or inability to drink standard meal of Ensure Plus
- Estabished diagnosis of gastroparesis
Show all 51Show fewer
- Significant systemic or major illnesses including, but not limited to, stroke, congestive heart failure, renal failure (creatinine clearance < 50 ml/min), organ transplantation, angina pectoris, active malignancy, and autonomic neuropathy
- Unstable psychiatric conditions, untreated or uncontrolled depression or generalized anxiety disorder, substance abuse within the past year, in order to prevent feeling of being uncomfortable or to prevent lack of follow-up
- Use of not-steroidal anti-inflammatory drugs for 2 weeks prior to study enrollment
- Phase IIIA, Use in Patients with Refractory GERD, Peptic ulcer disease, Idiopathic Gastric Hypersecretion
- History of gastric surgery (gastrectomy, pyloroplasty).
- Use of bowel motility medications such as, but not limited to, Reglan, Immodium, and Lomotil
- Contraindication to SmartPill: history of gastric bezoar, disorders of swallowing, suspected strictures, fistulas, or physiological GI obstruction, GI surgery within the past three months, severe dysphagia to food or pills, Crohn s Disease or diverticulitis, a subject who uses an implanted or portable electro-mechanical medical device such as a cardiac pacemaker or infusion pump
- Pregnancy and breastfeeding. Females of childbearing potential must be on an acceptable means of birth control and no intercourse in 2 weeks prior to study enrollment.
- Lactose intolerance or inability to drink standard meal of Ensure Plus
- Established diagnosis of gastroparesis
- Significant systemic or major illnesses including, but not limited to, stroke, congestive heart failure, renal failure (creatinine clearance < 50 ml/min), organ transplantation, angina pectoris, active malignancy, and autonomic neuropathy
- Unstable psychiatric conditions, untreated or uncontrolled depression or generalized anxiety disorders, substance abuse within the past year, in order to prevent feeling of being uncomfortable or to prevent lack of follow-up. Use of non-steroidal anti-inflammatory drugs for 2 weeks prior to study enrollment.
- Phase IIIB, Use in Patients with Medication-Controlled: GERD, Peptic ulcer disease, Idiopathic Gastric Hypersecretion
- Refractory to medication: GERD (patients with persistant symptoms despite being on standard medical therapy), PUD, and suspected idiopathic gastric hypersecretion
- History of gastric surgery (gastrectomy, pyloroplasty).
- Use of bowel motility medications such as, but not limited to, Reglan, Immodium, and Lomotil
- Contraindication to SmartPill: history of gastric bezoar, disorders of swallowing, suspected strictures, fistulas, or physiological GI obstruction, GI surgery within the past three months, severe dysphagia to food or pills, Crohn s Disease or diverticulitis, a subject who uses an implanted or portable electro-mechanical medical device such as a cardiac pacemaker or infusion pump
- Pregnancy and breastfeeding. Females of childbearing potential must be on an acceptable means of birth control and no intercourse in 2 weeks prior to study enrollment.
- Lactose intolerance or inability to drink standard meal of Ensure Plus
- Established diagnosis of gastroparesis
- Significant systemic or major illnesses including, but not limited to, stroke, congestive heart failure, renal failure (creatinine clearance < 50 ml/min), organ transplantation, angina pectoris, active malignancy, and autonomic neuropathy
- Unstable psychiatric conditions, untreated or uncontrolled depression or genralized anxiety disorders, substance abuse within the past year, in order to prevent feeling of being uncomfortable or to prevent lack of follow-up
- Use of non-steroidal anti-inflammatory drugs for 2 weeks prior to study enrollment
- RECRUITMENT IS CLOSED FOR Phase IA/IB, Validation and Establishment of Nomogram in Healthy Volunteers
- PHASE IA/IB INCLUSION:
- Healthy volunteers
- Ages 18-60
- Males, females, all ethnicities
- PHASE IA/IB EXCLUSION:
- History of gastric or bowel surgery
- Use of bowel motility medications such as, but not limited to, Reglan, Immodium, and Lomotil
- Use of antacid, antisecretory, and anticholinergic medications such as, but not limited to, proton pump inhibitors and histamine 2 receptor antagonists
- Use of non-steroidal anti-inflammatory drugs for 2 weeks prior to study enrollment
- Hypersecretory and hyposecretory related conditions including, but not limited to, pernicious anemia, atrophic gastritis, and Zollinger-Ellison syndrome
- Contraindication to NGT: deviated septum, history of transphenoidal surgery, chronic sinusitis, severe facial trauma (cribriform plate disruption, sustained head trauma, maxillofacial injury, or anterior fossa skull fracture), esophageal stricture, esophageal varices, altered mental status, and impaired airway
- Contraindication to scintigraphy: allergy to sulfa-colloid
- Contraindication to pentagastrin: allergy to pentagastrin, active gastrointestinal bleeding, active peptic ulcer disease, active gallbladder and liver disease, pancreatitis, and bowel obstruction
- Contraindication to SmartPill: history of gastric bezoar, disorders of swallowing, suspected strictures, fistulas, or physiological GI obstruction, GI surgery within the past three months, severe dysphagia to food or pills, Crohns disease or diverticulosis, and implanted or portable electro-mechanical medical device such as a cardiac pacemaker or infusion pump
- Pregnancy and breastfeeding. Females of childbearing potential must be on an acceptable means of birth control and no intercourse in 2 weeks prior to study enrollment.
- Lactose intolerance or inability to drink standard meal of Ensure Plus
- Helicobacter pylori infection
- Gastroparesis
- History of gastroesophageal reflux disease, peptic ulcer disease, irritable bowel syndrome, or inflammatory bowel disease
- Significant systemic or major illnesses including, but not limited to, stroke, cardiovascular disease, hypertension, congestive heart failure, renal failure (creatinine clearance < 50 ml/min), organ transplantation, angina pectoris, active malignancy, diabetes, or autonomic neuropathy
- Unstable psychiatric conditions, depression, generalized anxiety disorder, or substance abuse within the past year, in order to prevent feeling of being uncomfortable or to prevent lack of follow-up
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Background:
- Acid-related gastrointestinal disorders are numerous and may require chronic treatment and maintenance, but they are often difficult to diagnose and treat. Gastric analysis is a critical tool for diagnosing and treating acid-related disorders; however, at present it requires a technically difficult procedure, using a nasogastric tube, that is costly, invasive, and uncomfortable. Recently a new tool, the SmartPill, has been developed that can measure acid levels, temperature, and pressure throughout the stomach, small intestine, and colon by swallowing a small capsule. Researchers are interested in comparing current methods of measuring stomach acid with the SmartPill by studying both healthy volunteers and individuals with acid-related gastrointestinal disorders.
Read more
Objectives:
- To evaluate the usefulness and accuracy of the SmartPill for gastric analysis, compared with current procedures.
Eligibility:
- Phase 1A/1B: Healthy volunteers between 18 and 60 years of age.
- Phase 2: Individuals at least 18 years of age who have been diagnosed with Zollinger-Ellison Syndrome or acid hypersecretion.
- Phase 3: Individuals at least 18 years of age who have been diagnosed with refractory gastroesophageal reflux disease, peptic ulcer disease, or idiopathic gastric hypersecretion.
Design:
- This study involves a screening visit, a 3-day inpatient study visit, and possible additional outpatient visits.
- Participants will be screened with a medical history and physical examination, as well as blood and urine samples.
- Phase 1A/1B: Participants will have a 3-day inpatient study visit with the following procedures:
- Imaging study of the stomach (simultaneous gastric emptying scintigraphy), followed by a special diet for the next day s test.
- Gastric analysis using a nasogastric tube to collect stomach acid secretions.
- SmartPill study, in which participants will ingest a SmartPill and wear a monitor for 24 to 48 hours to collect readings.
- Participants in Phase 1A will have a second outpatient SmartPill study 7 days after the first SmartPill study. Participants in Phase 1B will not have the second SmartPill study.
- Phase 2 and Phase 3: Participants will have a 3-day inpatient study visit with the following procedures:
- Imaging study of the stomach (simultaneous gastric emptying scintigraphy), followed by a special diet for the next day s test.
- Gastric analysis using a nasogastric tube to collect stomach acid secretions.
- SmartPill study, in which participants will ingest a SmartPill and wear a monitor for 24 to 48 hours to collect readings.
- Phase 2 and 3 participants will have outpatient study visits only if directed by the study researchers....
Read the detailed description
Acid related disorders are numerous and often require chronic treatment and maintenance. Many of these diseases are without symptoms and therefore difficult to diagnose and treat. Gastric analysis is the quantitative measurement of gastric acid output and is a critical tool for the diagnosis of acid related disorders and the ongoing assessment of therapy response. At present gastric analysis requires a technically difficult procedure, using gastric aspiration through a nasogastric tube, that is costly, invasive, and uncomfortable for patients. Recently there is introduction of the SmartPill, which is a disposable pill that measures pH, temperature, and pressure throughout the GI tract. We propose a pilot study to validate a new method of gastric analysis with the ingestion of the SmartPill with a meal of a known buffering capacity to measure both the acidity and quantity of acid output in the stomach. We will validate this method by comparing it to the accepted gastric aspiration method under maximally stimulated conditions. We will study healthy volunteers for the validation phase and then study patients with known acid related disorders to assess its usefulness in patients. Interested subjects will report to the NIH outpatient gastrointestinal clinic for evaluation to be followed by a 3 day in-patient admission and 2 subsequent clinic visits. Subjects will have gastric analysis of basal, meal stimulated, and pharmacologically stimulated rates with both the conventional and study methods. Outcomes will include a quantitative measurement of gastric acid output in unit time, normal meal stimulated acid output values in healthy volunteers and patients with acid related disorders, and the assessment of acid suppression in patients treated with a variety of anti-secretory medications.
- Conditions
- Gastric Acid Secretory Disorders
- Being tested
- Pentagastrin Injection BP, Pentagastrin
- Keywords
- Gastric Acid Output, Hyper/Hyposecretion, Gastric Analysis, Gastric pH, SmartPill, Natural History, Gastric Secretion, Healthy Volunteer, HV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pentagastrin Injection BPDevice
PentagastrinDrug
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Healthy volunteers between 18 and 60 years of age Receives: Device: Pentagastrin Injection BP | |
| patients with gastric acid secretory disorders | 18 years of age who have been diagnosed with Zollinger-Ellison Syndrome or acid hypersecretion. Receives: Device: Pentagastrin Injection BP; Drug: Pentagastrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
examines the safety and efficacy of disposable, wireless capsule (SmartPill)
This study examines the safety and efficacy of disposable, wireless capsule (SmartPill) devices in determining gastric acid output in comparison to current standard gastric aspiration procedures, which are more invasive and inconvenient.
Measured: until protocol closes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2008 (estimated)
- Study start18 Jun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Gastric Acid Secretory DisordersStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Stephen A Wank, M.D., Principal investigator, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00702533
- Sponsor's protocol ID
- 080138
- Other IDs
- 08-DK-0138
- Status last verified
- 16 Oct 2026
- First submitted
- 19 Jun 2008
- Last updated
- 26 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Shaheen NJ, Hansen RA, Morgan DR, Gangarosa LM, Ringel Y, Thiny MT, Russo MW, Sandler RS. The burden of gastrointestinal and liver diseases, 2006. Am J Gastroenterol. 2006 Sep;101(9):2128-38. doi: 10.1111/j.1572-0241.2006.00723.x. Epub 2006 Jul 18.
PubMed 16848807Bruley Des Varannes S, Marek L, Humeau B, Lecasble M, Colin R. Gastroesophageal reflux disease in primary care. Prevalence, epidemiology and Quality of Life of patients. Gastroenterol Clin Biol. 2006 Mar;30(3):364-70. doi: 10.1016/s0399-8320(06)73189-x.
PubMed 16633300El-Serag HB, Aguirre T, Kuebeler M, Sampliner RE. The length of newly diagnosed Barrett's oesophagus and prior use of acid suppressive therapy. Aliment Pharmacol Ther. 2004 Jun 15;19(12):1255-60. doi: 10.1111/j.1365-2036.2004.02006.x.
PubMed 15191506
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Method for Determining Gastric Acid Output Using a Wireless Capsule
- ClinicalTrials.gov ID
- NCT00702533
- Acronym / sponsor ID
- 080138
- Conditions
- Gastric Acid Secretory Disorders
- Keywords
- Gastric Acid Output, Hyper/Hyposecretion, Gastric Analysis, Gastric pH, SmartPill, Natural History, Gastric Secretion, Healthy Volunteer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- 18 Jun 2008
- First posted
- 20 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
- Acid-related gastrointestinal disorders are numerous and may require chronic treatment and maintenance, but they are often difficult to diagnose and treat. Gastric analysis is a critical tool for diagnosing and treating acid-related disorders; however, at present it requires a technically difficult procedure, using a nasogastric tube, that is costly, invasive, and uncomfortable. Recently a new tool, the SmartPill, has been developed that can measure acid levels, temperature, and pressure throughout the stomach, small intestine, and colon by swallowing a small capsule. Researchers are interested in comparing current methods of measuring stomach acid with the SmartPill by studying both healthy volunteers and individuals with acid-related gastrointestinal disorders.
Objectives:
- To evaluate the usefulness and accuracy of the SmartPill for gastric analysis, compared with current procedures.
Eligibility:
- Phase 1A/1B: Healthy volunteers between 18 and 60 years of age.
- Phase 2: Individuals at least 18 years of age who have been diagnosed with Zollinger-Ellison Syndrome or acid hypersecretion.
- Phase 3: Individuals at least 18 years of age who have been diagnosed with refractory gastroesophageal reflux disease, peptic ulcer disease, or idiopathic gastric hypersecretion.
Design:
- This study involves a screening visit, a 3-day inpatient study visit, and possible additional outpatient visits.
- Participants will be screened with a medical history and physical examination, as well as blood and urine samples.
- Phase 1A/1B: Participants will have a 3-day inpatient study visit with the following procedures:
- Imaging study of the stomach (simultaneous gastric emptying scintigraphy), followed by a special diet for the next day s test.
- Gastric analysis using a nasogastric tube to collect stomach acid secretions.
- SmartPill study, in which participants will ingest a SmartPill and wear a monitor for 24 to 48 hours to collect readings.
- Participants in Phase 1A will have a second outpatient SmartPill study 7 days after the first SmartPill study. Participants in Phase 1B will not have the second SmartPill study.
- Phase 2 and Phase 3: Participants will have a 3-day inpatient study visit with the following procedures:
- Imaging study of the stomach (simultaneous gastric emptying scintigraphy), followed by a special diet for the next day s test.
- Gastric analysis using a nasogastric tube to collect stomach acid secretions.
- SmartPill study, in which participants will ingest a SmartPill and wear a monitor for 24 to 48 hours to collect readings.
- Phase 2 and 3 participants will have outpatient study visits only if directed by the study researchers....
Detailed description
Acid related disorders are numerous and often require chronic treatment and maintenance. Many of these diseases are without symptoms and therefore difficult to diagnose and treat. Gastric analysis is the quantitative measurement of gastric acid output and is a critical tool for the diagnosis of acid related disorders and the ongoing assessment of therapy response. At present gastric analysis requires a technically difficult procedure, using gastric aspiration through a nasogastric tube, that is costly, invasive, and uncomfortable for patients. Recently there is introduction of the SmartPill, which is a disposable pill that measures pH, temperature, and pressure throughout the GI tract. We propose a pilot study to validate a new method of gastric analysis with the ingestion of the SmartPill with a meal of a known buffering capacity to measure both the acidity and quantity of acid output in the stomach. We will validate this method by comparing it to the accepted gastric aspiration method under maximally stimulated conditions. We will study healthy volunteers for the validation phase and then study patients with known acid related disorders to assess its usefulness in patients. Interested subjects will report to the NIH outpatient gastrointestinal clinic for evaluation to be followed by a 3 day in-patient admission and 2 subsequent clinic visits. Subjects will have gastric analysis of basal, meal stimulated, and pharmacologically stimulated rates with both the conventional and study methods. Outcomes will include a quantitative measurement of gastric acid output in unit time, normal meal stimulated acid output values in healthy volunteers and patients with acid related disorders, and the assessment of acid suppression in patients treated with a variety of anti-secretory medications.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | – | Device: Pentagastrin Injection BPHealthy volunteers between 18 and 60 years of age |
| patients with gastric acid secretory disorders | – | Device: Pentagastrin Injection BP, Drug: Pentagastrin18 years of age who have been diagnosed with Zollinger-Ellison Syndrome or acid hypersecretion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteers and patients with gastric acid secretory disorders
Key inclusion criteria (16 listed)
- Zollinger-Ellison syndrome (ZES) as diagnosed by one of the following criteria: histologic confirmation of gastrinoma, positive provocative testing with secretin (an increase of >200 pg/mL postinjection), gastric acid hypersecretion (BAO > 15) in the presence of hypergastrinemia (fasting serum gastrin > 99)
- Multiple endocrine neoplasia type-I (MEN1) with suspicion of ZES (hypergastrinemia) undergoing evaluation. MEN-I with ZES
- Hypergastrinemia (serum gastrin > 99)
- Ages equal to or greater than 18 years
- Male, females, all ethnicities
Key exclusion criteria (51 listed)
- History of gastric surgery (gastrectomy, pyloroplasty)
- Use of bowel motility medications such as, but not limited to, Reglan, Immodium, and Lomotil
- Contraindication to SmartPill: history of gastric bezoar, disorders of swallowing, suspected strictures, fistulas, or physiological GI obstruction, GI surgery within the past three months, severe dysphagia to food or pills, Crohn s Disease or diverticulitis, a subject who uses an implanted or portable electro-mechanical medical device such as a cardiac pacemaker or infusion pump
- Pregnancy and breastfeeding. Females of childbearing potential must be on an acceptable means of birth control and no intercourse in 2 weeks prior to study enrollment.
- Lactose intolerance or inability to drink standard meal of Ensure Plus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pentagastrin Injection BP | Device | Healthy volunteers, patients with gastric acid secretory disorders |
| Pentagastrin | Drug | patients with gastric acid secretory disorders |
Primary outcome
examines the safety and efficacy of disposable, wireless capsule (SmartPill)
Time frame: until protocol closes
This study examines the safety and efficacy of disposable, wireless capsule (SmartPill) devices in determining gastric acid output in comparison to current standard gastric aspiration procedures, which are more invasive and inconvenient.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Background: PubMed 16848807Shaheen NJ, Hansen RA, Morgan DR, Gangarosa LM, Ringel Y, Thiny MT, Russo MW, Sandler RS. The burden of gastrointestinal and liver diseases, 2006. Am J Gastroenterol. 2006 Sep;101(9):2128-38. doi: 10.1111/j.1572-0241.2006.00723.x. Epub 2006 Jul 18.
- Background: PubMed 16633300Bruley Des Varannes S, Marek L, Humeau B, Lecasble M, Colin R. Gastroesophageal reflux disease in primary care. Prevalence, epidemiology and Quality of Life of patients. Gastroenterol Clin Biol. 2006 Mar;30(3):364-70. doi: 10.1016/s0399-8320(06)73189-x.
- Background: PubMed 15191506El-Serag HB, Aguirre T, Kuebeler M, Sampliner RE. The length of newly diagnosed Barrett's oesophagus and prior use of acid suppressive therapy. Aliment Pharmacol Ther. 2004 Jun 15;19(12):1255-60. doi: 10.1111/j.1365-2036.2004.02006.x.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen A Wank, M.D. principal investigator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Acid Secretory Disorders, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 51 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
examines the safety and efficacy of disposable, wireless capsule (SmartPill) (time frame: until protocol closes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00702533, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.